A Dose Ranging Study of Arformoterol Given Once Daily Compared to Arformoterol Given Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00691405
Last Updated: 2012-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
215 participants
INTERVENTIONAL
2003-10-31
2004-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A1
Arformoterol 5 mcg BID for 14 days
Arformoterol tartrate inhalation solution
Arformoterol 5 mcg BID
A2
Arformoterol 15 mcg BID for 14 days
Arformoterol tartrate inhalation solution
Arformoterol 15 mcg BID
A3
Arformoterol 25 mcg BID for 14 days
Arformoterol tartrate inhalation solution
Arformoterol 25 mcg BID
A4
Placebo inhalation solution BID for 14 days
Placebo
Placebo inhalation solution BID
B1
Arformoterol 15 mcg QD for 14 days
Arformoterol tartrate inhalation solution
Arformoterol 15 mcg QD
B2
Arformoterol 25 mcg QD for 14 days
Arformoterol tartrate inhalation solution
Arformoterol 25 mcg QD
B3
Arformoterol 50 mcg QD for 14 days
Arformoterol tartrate inhalation solution
Arformoterol 50 mcg QD
B4
Placebo inhalation solution QD for 14 days
Placebo
Placebo inhalation solution QD
Interventions
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Arformoterol tartrate inhalation solution
Arformoterol 5 mcg BID
Arformoterol tartrate inhalation solution
Arformoterol 15 mcg BID
Arformoterol tartrate inhalation solution
Arformoterol 25 mcg BID
Placebo
Placebo inhalation solution BID
Arformoterol tartrate inhalation solution
Arformoterol 15 mcg QD
Arformoterol tartrate inhalation solution
Arformoterol 25 mcg QD
Arformoterol tartrate inhalation solution
Arformoterol 50 mcg QD
Placebo
Placebo inhalation solution QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female subject less than or equal to 65 years of age must have a serum pregnancy test conducted at study start and confirmed negative. Subjects of childbearing potential must be using an acceptable method of birth control and agree to continue its use throughout the study.
* In order to be considered not of childbearing potential female subjects must be:
* documented surgically sterile (defined as status post-hysterectomy or bilateral tubal ligation) OR
* postmenopausal
* Subject must have a primary diagnosis of COPD, which may include components of chronic bronchitis and/or emphysema. Diagnosis can be made during the screening process.
* Subject must have a minimum smoking history of 15 pack-years (pack-years = the number of cigarette packs per day times the number of years).
* Subject must have a chest x-ray that is consistent with the diagnosis of COPD (e.g., not diagnostic of pneumonia, other infection, atelectasis, or pneumothorax) and taken less than or equal to 6 months before study start. If there is no chest x-ray taken less than or equal to 6 months before study start, a chest x-ray will be performed at Visit 1.
* Subject must be able to complete all study questionnaires and logs reliably.
Exclusion Criteria
* Subject who has participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another investigational drug study.
* Subject's schedule or travel prevents the completion of all required visits.
* Subject is scheduled for in-patient hospitalization, including elective surgery (in patient or out-patient) during the trial.
* Subject has had a life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the 30 days prior to study start.
* Subject has a known history of asthma (except childhood asthma) or any chronic respiratory disease (including a current history of sleep apnea) other than COPD (chronic bronchitis and/or emphysema).
* Subject has a known history of alpha 1 antitrypsin deficiency-related emphysema.
* Subject has a history of cancer except non-melanoma skin cancer. Subjects with a history of cancer that is considered surgically cured and without a recurrence within the past 5 years may participate in the study. History of hematologic/lymphatic malignancy treated with chemotherapy or radiation is not allowed, under any condition.
* Subject has a history of lung resection of more than one full lobe or being a recipient of a lung or major organ transplant.
* Subject requires continuous supplemental oxygen therapy (unless subject resides at elevation greater than or equal to 4,000 feet).
* Subject has had a change in dose or type of any medications for COPD within 14 days before the screening visit.
* Subject has a known sensitivity to arformoterol, ipratropium or albuterol or any of the excipients contained in any of these formulations.
* Subject has a history of substance abuse within 12 months of Visit 1, or with a positive urine drug screen at study start.
* Subject is using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers).
* Subject has had significant blood loss (\>500 cc) or donated blood within 60 days preceding screening or plans to donate blood during or within 60 days after completing the study.
35 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Locations
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Encinitas, California, United States
Long Beach, California, United States
Brandon, Florida, United States
Cleawater, Florida, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Port Orange, Florida, United States
West Palm Beach, Florida, United States
Austell, Georgia, United States
Topeka, Kansas, United States
Marrero, Louisiana, United States
New Orleans, Louisiana, United States
Opelousas, Louisiana, United States
McCook, Nebraska, United States
Princeton, New Jersey, United States
Hickory, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Eugene, Oregon, United States
Medford, Oregon, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Simpsonville, South Carolina, United States
Spartanburg, South Carolina, United States
Austin, Texas, United States
San Antonio, Texas, United States
Renton, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Countries
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Other Identifiers
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091-026
Identifier Type: -
Identifier Source: org_study_id
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